Chris Panteli & Sarah Gunston

  • Data Science & Analytics
  • Change Management

– 16 Jul, 2019

Risk Based Quality Management (RBQM)

Last month consultants Chris Panteli and Sarah Gunston held a webinar to discuss Risk Based Quality Management (RBQM) and what this means for clinicians in the pharmaceutical industry.

In case you missed it, they have summarised the insights here and you can watch the full webinar at the end of this article.

Risk management itself is not a difficult concept to grasp although it is represented on a number of different levels, methodologies and visualisations. The concept of looking to the future and trying to identify scenarios which may happen is a bit more difficult.

Essentially the culture of life sciences is to focus on the task in hand today, check and double check everything and find the root cause of issues which affect the quality of delivery of that task.

Here we’ll outline some definitions:

  • Risk is an event (or set of circumstances) that, should it occur, would have an effect, positive or negative, on the outcome of a clinical trial. Risks with a positive impact are called opportunities while those with negative impacts are called threats.
  • Uncertainty derives from an imperfect knowledge and can be represented as a range of possible outcomes. If the range of possibilities could cause decisions to change, will the uncertainty translate into a specific event.
  • Risk Based Quality Management (RBQM) is a systematic process put in place to identify, assess, control, communicate and review the risks associated with clinical trial during its life cycle (Reflection paper on risk-based quality management in clinical trials, EMA/ 269011/ 2013).

The prime objective of risk management is to improve the business performance by avoiding unexpected quality events and reducing the frequency of poor outcomes.

From what we have seen with our clients’ work, the effective management of risk is critical to the continual improvement in clinical trial performance both in individual products and overall asset portfolio.

In our experience, the key barrier to the effective Risk Based Quality Management is the culture established within life sciences where 100% Source Data Verification (SDV) has been key to protecting patient rights and safety and the quality of data, thus retaining the integrity of the clinical trial. To effectively implement RBQM requires a change of culture and integration of technology.

Organisations are changing all the time through restructuring to become more efficient, to reduce costs and to innovate, which are tactical and tangible changes to meet a competitive need.

However, to change a culture to one that is less risk adverse and eliminates the desire to check and report on everything is more challenging and less tangible. This is where clear guidance is required; how to do it, tactical knowledge and experience, not something offered by the regulatory guidelines which only focus on the what.

The key to achieving success in this area is to focus on the engagement of study teams and the benefits of good risk management. Companies who have good risk management practices embedded in their work processes consistently deliver more successful clinical trials.

When implemented properly it:

  • improves the likelihood of success through smarter decision making: encourages forward thinking, minimises sudden shocks and unwelcome surprises.
  • increase the visibility of risk: involves all stakeholders, thus raises risk awareness and enhances accountability.
  • enhances communication of risk: improves the basis for planning, performance management and decision making.
  • adds focus to clinical trial work: demonstrates how cross functional team activities play in the clinical trial risks, providing a better basis for the allocation of resources.

What we learnt from the webinar attendees was that many organisations have, or are still developing their Risk Based Monitoring processes, but are not using the management of risk at an early stage to eliminate or at least mitigate risk from the clinical protocol. An effective RBQM process starts at the early stage prior to the Final Protocol Milestone.

Starting early and using technology to engage a global cross functional team can help deliver a de-risked protocol before engaging vendors and kicking off the study process. Using proportional effort to conduct and report on the clinical trial then becomes a more attractive proposition.

If you would like to discuss your RBQM strategy or have any questions, please feel free to get in touch with Chris Panteli or Sarah Gunston.

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